An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)

Implementation of a Nurse-Led Educational Intervention on Adverse Effects of Antihypertensive Drugs in Patients With Resistant Hypertension: Focus on Sexual Dysfunction, Urinary Incontinence, and Qualitative Insights.

This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.

Inclusion Criteria:

• Adults aged 18 to 75 years.
• Diagnosis of resistant hypertension, defined as blood pressure not controlled despite the use of three or more antihypertensive medications.
• Uncontrolled blood pressure as measured by ambulatory blood pressure monitoring (ABPM).
• Resistant hypertension not secondary to other medical conditions (i.e., primary or essential hypertension).
• No use of antihypertensive medications other than the prescribed ones, and no intake of licorice (which can interfere with blood pressure).

Exclusion Criteria:

• Secondary causes of hypertension (e.g., endocrine disorders like hyperaldosteronism, pheochromocytoma, etc.).
• Severe cognitive impairment that would prevent the patient from understanding the intervention or providing informed consent.
• Uncontrolled psychiatric conditions that would interfere with participation (e.g., severe depression or psychosis).
• Hospitalization during the study period.
• Change of treatment regimen antihypertensive by a physician outside the study team (e.g., switching antihypertensive drugs or adding new medications without prior consultation with the study team).
• Participation in another clinical trial that might interfere with the study outcomes.
• Any other condition deemed inappropriate for study participation by the investigator.